Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adverse Events Related to Treatments Used Against Coronavirus Disease 2019 (CovidTox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314817
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
CMC Ambroise Paré
Information provided by (Responsible Party):
Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Condition or disease Intervention/treatment
Coronavirus Iatrogenic Disease Acute Kidney Injury ARDS, Human Drug: Any drug used to treat Covid-19

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Actual Study Start Date : March 17, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2023


Group/Cohort Intervention/treatment
Patients treated for Covid-19 Drug: Any drug used to treat Covid-19
lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.




Primary Outcome Measures :
  1. Renal failure [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms


Secondary Outcome Measures :
  1. Heart failure [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  2. EKG disturbance [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  3. Hepatic failure [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  4. Anemia [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  5. Leucopenia [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  6. Vascular disease [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  7. Toxidermia [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  8. Osteoarticular adverse event [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  9. Death [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  10. Acute respiratory distress syndrome [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

  11. Pulmonary embolism or pulmonary hypertension [ Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020 ]
    defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with a drug that could be reported in the WHO's pharmacovigilance database and with a plausible indication against Covid-19
Criteria

Inclusion Criteria:

  • all patients treated for Covid-19

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314817


Contacts
Layout table for location contacts
Contact: Lee S Nguyen, MD, PhDc 0033158414143 nguyen.lee@icloud.com

Locations
Layout table for location information
France
AP-HP Assistance Publique Hopitaux de Paris Recruiting
Paris, France
Contact: Lee S Nguyen, MD, PhDc         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
CMC Ambroise Paré
Investigators
Layout table for investigator information
Study Director: Joe-Elie Salem, MD, PhD Clinical Investigations Center
Layout table for additonal information
Responsible Party: Lee S Nguyen, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT04314817    
Other Study ID Numbers: CIC1421-20-04
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data is available per se. They need to be retrieved from the World Health Organization.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Respiratory Distress Syndrome, Adult
Acute Kidney Injury
Iatrogenic Disease
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Disease Attributes
Pathologic Processes